NCT02386514

Emergency Department, Rapid Assessment for Sexually Transmitted Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.

Detailed description

All patients presenting to the Emergency Department during the study period who are tested for gonorrhea and chlamydia by the traditional swab NAAT will concurrently have their urine tested for gonorrhea and chlamydia using the Cepheid GeneXpert rapid NAAT. The result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional NAAT. Both the traditional and Cepheid GeneXpert rapid NAAT are FDA and CDC approved for evaluation of gonorrhea and chlamydia. However, the Cepheid GeneXpert rapid NAAT has not been prospectively validated in the Emergency Department setting. We intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional NAAT. The Cepheid GeneXpert rapid NAAT will not be used in patient care decisions.

Conditions

• Infection

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-03-12
• Last updated: 2017-01-04

Locations

1 site across 1 country: United States